Five simple, selective, and rapid spectrophotometric methods are developed for the determination of flibanserin (FL) in the presence of its oxidative degradation products (ODPs). Stress studies are performed according to the International Conference on Harmonization (ICH) guidelines to assess the behavior of FL against oxidative, thermal, and acidic conditions. FL was stable against thermal and acidic conditions, while it was susceptible to oxidative degradation. Three of the spectrophotometric methods were univariate methods, namely, third derivative (D³), ratio difference of ratio spectra (RD), and first derivative ratio of spectra (D¹R), while the other two methods were multivariate methods, namely, partial least square (PLS) and principal components regression (PCR). No preliminary separation steps were required in these methods. The chemical structures of the ODPs were confirmed using mass spectrometry and ¹H NMR spectroscopy. The proposed methods were developed and validated according to the ICH guidelines. The linearity, accuracy, and precision were determined, and the selectivity was assessed by analyzing synthetic laboratory mixtures containing different ratios of FL and its ODPs. Statistical comparisons were applied to the five spectrophotometric methods, and no significant differences were found. The validated methods could be applied for routine testing and quality control.

开发了五种简单，选择性和快速的分光光度法，用于在氟班色林（FL）氧化降解产物（ODP）存在下的测定。根据国际协调会议（ICH）指南进行压力研究，以评估FL在氧化，热和酸性条件下的行为。FL在热和酸性条件下均稳定，同时易于氧化降解。分光光度法中的三种是单变量方法，即三阶导数（D ³），比率光谱的比率差（RD）和光谱的一阶导数比率（D ^1）。R），而其他两种方法是多元方法，即偏最小二乘（PLS）和主成分回归（PCR）。这些方法不需要预先的分离步骤。使用质谱和¹ H NMR光谱确认了ODP的化学结构。所提出的方法是根据ICH指南开发和验证的。确定了线性，准确性和精密度，并通过分析包含不同比例的FL及其ODP的合成实验室混合物来评估选择性。统计比较应用于五种分光光度法，没有发现显着差异。经验证的方法可用于常规测试和质量控制。